Medicines and Medical Devices Act 2021

2021 c. 3 · Enacted 11 February 2021 · Extends to United Kingdom

Contents

1. Part 1: The Commissioner for Patient Safety
2. 1Establishment and core duties etc
3. Part 2: Human medicines
4. Chapter 1: Regulations: general
5. 2Power to make regulations about human medicines
6. 3Manufacture, marketing and supply
7. 4Falsified medicines
8. 5Clinical trials
9. 6Fees, offences, powers of inspectors
10. 7Emergencies
11. Chapter 1A: Regulations: information systems
12. 7AInformation systems
13. 7BOffence of disclosing information
14. Chapter 2: International agreements: disclosure of information
15. 8Disclosure of information in accordance with international agreements
16. Chapter 3: Interpretation
17. 9Interpretation of Part 2
18. Part 3: Veterinary medicines
19. Chapter 1: Regulations
20. 10Power to make regulations about veterinary medicines
21. 11Manufacture, marketing, supply and field trials
22. 12Fees, offences, powers of inspectors, costs
23. Chapter 2: International agreements: disclosure of information
24. 13Disclosure of information in accordance with international agreements
25. Chapter 3: Interpretation etc
26. 14Interpretation of Part 3 and supplementary provision
27. Part 4: Medical devices
28. Chapter 1: Regulations: general
29. 15Power to make regulations about medical devices
30. 16Manufacture, marketing and supply
31. 17Fees, information, offences
32. 18Emergencies
33. Chapter 2: Regulations: information systems, advisory committee
34. 19Information systems
35. 20Advisory committee
36. Chapter 3: Enforcement
37. Enforcement notices
38. 21Compliance notices
39. 22Suspension notices
40. 23Safety notices
41. 24Information notices
42. 25Applications to set notices aside etc
43. 26Compensation
44. 27Further appeals
45. Offences
46. 28Offences
47. 29Defence of due diligence
48. 30Offences by bodies corporate
49. Civil sanctions Not yet in force
50. 31Civil sanctions Not yet in force
51. Forfeiture
52. 32Forfeiture of medical devices
53. 33Appeals against forfeiture decisions
54. Recovery of expenses of enforcement
55. 34Recovery of expenses of enforcement
56. Recall of medical device by enforcement authority
57. 35Recall of medical device by enforcement authority
58. Power of officer of Revenue and Customs to detain medical device
59. 36Power of officer of Revenue and Customs to detain medical device
60. 37Offence of obstructing an officer of Revenue and Customs
61. Civil proceedings
62. 38Civil proceedings
63. Chapter 4: Disclosure of information and consequential etc provision
64. Disclosure of information
65. 39Disclosure of information
66. 40Offences relating to information
67. Consequential etc provision
68. 41Consequential and supplementary provision
69. Chapter 5: Interpretation of Part 4
70. 42Interpretation of Part 4
71. Part 5: Regulations under Parts 1, 2, 3 and 4
72. 43Power to make consequential etc provision
73. 44Scope of powers of Northern Ireland departments
74. 45Consultation
75. 46Reporting requirements
76. 47Procedure
77. Part 6: Report on operation of medicines and medical devices legislation
78. 48Report on operation of medicines and medical devices legislation
79. Part 7: Extent, commencement and short title
80. 49Extent
81. 50Commencement
82. 51Transitional etc provision in connection with commencement
83. 52Short title
84. Schedule 1: Further provision about the Commissioner for Patient Safety
85. Principles relating to core duties
86. 1Paragraph 1
87. Involvement of patients
88. 2Paragraph 2
89. Supplementary functions and information
90. 3Paragraph 3
91. Individual cases
92. 4Paragraph 4
93. Amendments to primary legislation
94. 5Paragraph 5
95. Regulations about appointment and operation
96. 6Paragraph 6
97. Schedule 2: Medical devices: civil sanctions Not yet in force
98. Part 1: Monetary penalties Not yet in force
99. Imposition of monetary penalty Not yet in force
100. 1Paragraph 1 Not yet in force
101. Notices, representations and appeals etc Not yet in force
102. 2Paragraph 2 Not yet in force
103. Information to be included in notices under paragraph 2 Not yet in force
104. 3Paragraph 3 Not yet in force
105. Monetary penalties: criminal proceedings and conviction Not yet in force
106. 4Paragraph 4 Not yet in force
107. Part 2: Enforcement undertakings Not yet in force
108. 5Paragraph 5 Not yet in force
109. Part 3: Enforcement costs recovery notices Not yet in force
110. Imposition of enforcement costs recovery notices Not yet in force
111. 6Paragraph 6 Not yet in force
112. Information to be included in enforcement costs recovery notices Not yet in force
113. 7Paragraph 7 Not yet in force
114. Appeals Not yet in force
115. 8Paragraph 8 Not yet in force
116. Part 4: Power to make supplementary provision etc by regulations Not yet in force
117. Supplementary regulations: general Not yet in force
118. 9Paragraph 9 Not yet in force
119. Monetary penalties and costs Not yet in force
120. 10Paragraph 10 Not yet in force
121. Enforcement undertakings Not yet in force
122. 11Paragraph 11 Not yet in force
123. Appeals Not yet in force
124. 12Paragraph 12 Not yet in force
125. Part 5: General and supplemental Not yet in force
126. Guidance as to enforcement Not yet in force
127. 13Paragraph 13 Not yet in force
128. Pre-commencement consultation Not yet in force
129. 14Paragraph 14 Not yet in force
130. Reports on use of civil sanctions Not yet in force
131. 15Paragraph 15 Not yet in force
132. Disclosure of information Not yet in force
133. 16Paragraph 16 Not yet in force
134. Part 6: Interpretation Not yet in force
135. 17Paragraph 17 Not yet in force
136. Schedule 3: Offence of breaching provisions in the Medical Devices Regulations 2002 Not yet in force
137. Part 1: Offence Not yet in force
138. 1Paragraph 1 Not yet in force
139. Part 2: Provisions Not yet in force
140. 2Paragraph 2 Not yet in force